Method for treating obesity by extracting food

ABSTRACT

The present invention is directed to an apparatus and method for treating obesity. An artificial obstruction is introduced into the patient&#39;s gastrointestinal tract, and a tube is positioned that passes through a patient&#39;s abdominal wall into the upper digestive system of the patient. The patient is allowed to carry out his/her everyday affairs including ingesting food. After the patient has ingested food, the food is extracted by pumping it out of the upper digestive system through the tube. The present invention is less invasive than current surgical procedures for reducing weight and allows patients to live a normal and active lifestyle without experiencing adverse side effects.

RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patentapplication Ser. No. 11,191,466, filed Jul. 27, 2005, which is acontinuation-in-part application of U.S. patent application Ser. No.10/702,194, filed Nov. 4, 2003, which claims the benefit of U.S.Provisional Application No. 60/423,645, filed Nov. 4, 2002, each ofwhich is incorporated by reference herein; and said application Ser. No.11/191,466 also claims priority to U.S. Provisional Application No.60/600,496, filed Aug. 10, 2004 and U.S. Provisional Application No.60/618,346, filed Oct. 12, 2004, each of which is incorporated byreference herein.

BACKGROUND OF THE INVENTION

Obesity is a major health problem in the United States and othercountries. The National Health and Nutrition Examination Survey(1988-1994) reported that approximately 20-25% of Americans are obese,while another study estimated the percentage of overweight Americans tobe between 60% and 65% (Flegal K M, Carroll M D, Ogden C L, Johnson C L“Prevalence and trends in obesity among US adults, 1999-2000” JAMA 2002;288:1723-1727). Obesity can cause numerous health problems, includingdiabetes, degenerative joint disease, hypertension, and heart disease.Weight reduction can be achieved by increased caloric expenditurethrough exercise and/or by reduced caloric consumption through diet.However, in most cases, weight gain often recurs and improvements inrelated co-morbidities are often not sustained.

Surgical procedures present an increasingly common solution for obesepatients. Surgical procedures include, for example, stapledgastroplasty, banded gastroplasty, gastric banding, gastric bypasssurgery, and bilopancreatic bypass. However, these surgical proceduresare invasive, risky and expensive to perform, and many patients regain asubstantial portion of the lost weight.

SUMMARY OF THE INVENTION

The present invention is directed to apparatuses and methods fortreating obesity or facilitating weight loss. A passageway is introducedinto a patient's upper digestive system such that it passes through thepatient's abdominal wall. The patient is allowed to carry out his/hereveryday affairs including ingesting food. After the patient hasingested food, the food is extracted by pumping it out of the upperdigestive system through the passageway. This approach is less invasivethan the procedures discussed above, easy to perform, easy to reverseand has successfully resulted in significant weight loss in obesepatients.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a first embodiment of the presentinvention installed in a patient;

FIG. 1A is a schematic view of a tube;

FIG. 1B is an alternate view of a tube;

FIG. 1C is a cross sectional schematic view of a tube;

FIG. 2 is a schematic view of a variation of an embodiment of thepresent invention that uses a manual bulb pump;

FIG. 3 is a schematic view of a variation of an embodiment of thepresent invention that uses a syringe as a pump;

FIG. 4 is a schematic view of a variation of an embodiment of thepresent invention that uses a bag connected to a pump;

FIG. 5 is a schematic view of how an embodiment of the present inventioncan be cleaned;

FIG. 6 is a schematic view of a second embodiment of the presentinvention that uses an inflated balloon anchor;

FIG. 7 is an axial cross sectional schematic view showing valvesprovided in the lumens of a tube in an embodiment of the presentinvention;

FIG. 8 is a schematic view of a third embodiment of the presentinvention having a tube with two balloons attached to that portion ofthe tube that is disposed within the patient's digestive system;

FIG. 9 is a schematic view of a fourth embodiment of the presentinvention having a tube with a curved configuration and a plurality ofholes in a sidewall;

FIG. 10 is a schematic view of a fifth embodiment of the presentinvention having a tube with a curved configuration, multiple holes in asidewall, and a morcellation device housed within a cage at its distalend portion;

FIG. 11 is a schematic view of the proximal end portion of a tube lyingsubstantially flush with a patient's abdominal wall;

FIG. 12 is a schematic view of a luer lock at the proximal end portionof a tube;

FIG. 13 is a schematic view of a variation of an embodiment of thepresent invention having a tube with a funnel shaped tip;

FIG. 14 is a schematic view of a sixth embodiment of the presentinvention having two intake tubes;

FIG. 15A and FIG. 15B are schematic views of an embodiment of thepresent invention installed in a patient illustrating how the apparatusaccommodates changes in thickness of the abdominal wall of a patient;

FIG. 16 illustrates how an embodiment of the present invention installedin a patient is used.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

As used herein, the term “food” includes both solid and liquidsubstances that have been ingested by the patient, the term “ingest” or“ingested” includes eating and drinking, and the term “upper digestivesystem” includes the stomach 3, duodenum 4 and proximal jejunum of thepatient.

In a first embodiment of the present invention as shown in FIG. 1, atransabdominal tube 1 is placed through a patient's abdominal wall suchthat a distal end portion 17 of the tube 1 is disposed inside thestomach 3 of the patient and a proximal end portion 16 of the tube 1extends out from the skin 5 of the patient. The tube 1 preferably has adiameter that is 20 to 36 French in size (1 French=⅓ mm). Mostpreferably, the diameter is greater than 28 French and the tube resistscollapsing when extraction is performed. Optionally, the tube 1 may bestiffened, made durable and less collapsible by, for example, braidingthe tube using nylon. Alternatively, the tube may be wrapped with wirematerial. Suitable materials for the tube 1 include polyurethane,silicone and other similar materials. The tube 1 may be opaque.

A retention member is attached to the tube 1 to prevent the tube 1 fromfalling out of the patient. In one embodiment, the retention member isinflatable such as the inflation portion 2 (balloon anchor) shown inFIG. 1. As shown in FIG. 1, the inflation portion 2 is provided at thedistal end portion 17 of the tube 1 to prevent the tube 1 from comingout of the stomach 3. FIG. 1 also illustrates a non-inflatable retentionmember flange 2′ at the proximal end portion 16 of the tube 1 to preventthe tube 1 from falling into the patient's upper digestive system. A cap13 is detachably provided at the end of the proximal end portion 16 andseals the tube 1 when it is attached. The cap 13 is removed when a pump8, 9 (shown in FIGS. 2 and 3, respectively) is attached to the tube 1 toremove food from the upper digestive system of the patient.

Reference is now made to methods which may be used to insert the tube 1.These methods entail less risk of complications and less cost thanconventional, surgical methods of treating obesity, and patients whoundergo these treatments are typically discharged the same day of theoperation. These methods are therefore especially advantageous for usein treating obese patients because such patients are at increased riskfor surgical complications due to their obesity.

The tube 1 may be inserted, for example, through a procedure similar toinsertion of feeding tubes by Percutaneous Endoscopic Gastrostomy (PEG).A variety of methods of performing PEG are well known in the art, andany one of the methods may be used to insert the tube 1. PEG procedureshave been successfully completed in over 90 percent of attempts. PEG maybe performed under conscious sedation induced by, for example,meperidine and midazolam. According to one method of PEG known as thepull method, an endoscope is inserted into the stomach through the mouthof the patient. The stomach is insufflated by blowing air into thestomach through the endoscope. The insufflation brings the stomach inapposition to the abdominal wall and allows for direct access from theskin to the stomach of the patient.

An insertion site is located by surveying the interior of the stomachwith the endoscope. The endoscope is then used to illuminate theselected insertion site in such a way that the light of the endoscope isvisible from outside of the patient's body through the skin of thepatient.

An incision is made at the place on the patient's skin indicated by thelight from the endoscope and at the corresponding location on theexterior wall of the stomach. A cannula is then inserted through theincision and a guide wire is inserted into the stomach through thecannula. Graspers on the end of the endoscope grab hold of the distalportion of the guide wire in the stomach and the endoscope is withdrawnfrom the patient while the graspers hold the guide wire. The guide wireis of sufficient length to allow a proximal portion of it to extend outof the patient from the cannula after the distal portion is withdrawnfrom the stomach and through the patient's mouth by the endoscope.

The end of the guide wire extending out from the patient's mouth isattached to the proximal end of the tube 1, which is drawn though themouth and esophagus and into the stomach of the patient by pulling onthe proximal end of the guide wire. The tube 1 is then pulled throughthe incision in the stomach and skin of the patient until only thedistal end portion 17 and the inflation portion 2 of the tube 1 remaininside of the stomach. Optionally, the tube 1 may have a coned tip tohelp move the tube 1 through the incision in the stomach. Optionally, awire at the tip of the cone may be used for pulling the tube 1 throughthe incision. Once the tube 1 is in place, the coned tip may be cut off.The cannula is removed as the proximal end 16 of the tube 1 is drawnthrough the incision in the stomach, and is removed entirely when theproximal end 16 of the tube 1 is disposed at the patient's skin. Theinflation portion 2 of the tube 1 is then inflated by introducing fluidinto the inflation portion 2 through the inflation lumen 26. Theinflated inflation portion holds the tube 1 in place and the guide wireis removed from the tube 1. A non-inflatable retention member such as aflange 2′ may be placed on the proximal end portion 16 of the tube 1 tokeep the tube 1 disposed at the patient's skin.

An alternate method of PEG known as push PEG may also be used to insertthe tube 1. The tube 1 is pushed through the incision in the stomach andthe skin of the patient until it is disposed as described hereinabovewith respect to the pull method.

A third method which may be used for inserting the tube 1 via PEG isknown as the Russell method. As with both the push method and the pullmethod, the insertion site is located via endoscopy. An incision is madein the skin and stomach and a guide wire is inserted through theincision into the stomach via a cannula or needle. A dilator (orintroducer) with a peel away sheath is guided along the guide wire andinserted into the stomach. After the dilator (introducer) and sheath areinside the gastric lumen, the dilator is removed and the tube 1 isinserted along the guide wire and through the peel away sheath. Thesheath is then peeled away and the tube 1 is fixed in place.

The tube 1 may also be inserted without using an endoscope, for example,through a procedure similar to insertion of feeding tubes byPercutaneous Radiological Gastrostomy (PRG). According to PRG, thestomach is insufflated via a nasogastric tube. Organs which may beinterposed between the stomach and the abdominal wall, such as thecolon, are excluded by CT scan or ultrasonography. Exclusion ofinterposed organs may also be accomplished after insufflation byfluoroscopy. The selection of the insertion site is also determined byfluoroscopy or a similar method.

After the insertion site has been located, the tube 1 may be insertedtransabdominally as in the Russell method of PEG. Alternatively, a guidewire may be inserted as in the endoscopic pull method. The wire is thenmaneuvered through the stomach and esophagus and out of the patient'smouth and is used to guide the tube 1 back through the mouth, esophagusand stomach and out of the insertion site (see, e.g., Mustafa N. Zmen etal. “Percutaneous Radiologic Gastrostomy” European Journal of Radiology43:186-95).

The tube 1 may be inserted surgically. One suitable surgical techniquethat may be used to insert the tube 1 is the laparoscopic method. Inthis method, after pneumoperitoneum has been created, a 5 mm trocar isused to grasp a site on the anterior stomach wall that is appropriatefor tube placement without excessive tension on the stomach. A skinincision down to the rectus sheath is made. A trocar is placed throughthe rectus sheath and the stomach wall is grasped and pulled upwards. Anincision is made in the stomach and the tube 1 is inserted. Using theretention member at the distal end portion 17 of the tube 1, the stomachis brought snugly against the abdominal wall. The tissue is suturedaround the tube 1. (see, e.g., Andrew Luck et al. “LaparoscopicGastrostomy: Towards the Ideal Technique” Aust. N. Z. J. Surg. (1998)68:281-283).

The tube 1 may be inserted in other portions of the upper digestivesystem besides the stomach. For example, direct jejunostomy, wherein atube is inserted transabdominally into the jejunum, may be accomplishedthrough methods similar to those described hereinabove with reference togastrostomy tube placement. The retention member of the device shouldgenerally be smaller for jejunostomy procedures to avoid irritation ofthe jejunum or obstruction of the jejunal lumen.

FIG. 1 illustrates an inflatable retention member, i.e. the inflationportion 2, that is attached to the tube 1 to prevent the tube 1 fromfalling out of the patient. FIGS. 1, 1A and 1B illustrate twoalternative non-inflatable retention members that may be used in placeof and/or in addition to the inflatable portion 2. FIGS. 1 and 1Aillustrate a flange 2′ and FIG. 1B illustrates a dome 2″. A flange 2′ ordome 2″ that is located at the distal end portion 17 of the tube 1 helpsto prevent the tube 1 from coming out of the stomach 3 or other sectionof the upper digestive system. A flange 2′ or dome 2″ that is located atthe proximal end portion 16 of the tube 1 helps to prevent the tube fromfalling into the patient's upper digestive system.

When an inflatable retention member is used, the tube 1 preferably hasan inflation lumen 26 so that the inflatable retention member can beinflated. FIG. 1C shows a cross section of the tube 1 takenperpendicular to the axis of tube 1. Inflation lumen 26 extends from theinflation portion 2 to the proximal end portion 16 of the tube 1 and isa pathway for introducing fluid, such as water or air, to the inflationportion 2 from outside of the patient. Removal lumen 25 extends from theproximal end portion 16 to the distal end portion 17 of the tube 1 andis a pathway for the removal of food from the stomach 3 or other part ofthe upper digestive system of the patient. The inflation lumen 26 ispreferably minimal in size to allow the removal lumen 25 to be as wideas possible within the tube 1. In the illustrated embodiment, valves 15,27 are provided in lumens 25, 26, respectively, as shown in FIG. 7. Withthe non-inflatable retention members 2′ and 2″ shown in FIGS. 1A and 1B,the second lumen 26 in tube 1 can be eliminated.

Inflatable retention members are suitable for use with proceduressimilar to the push method, while either inflatable or rigid retentionmembers are suitable for use with procedures similar to the pull method.One example of a tube that has an inflatable retention member is taughtin Tiefenthal et al. (U.S. Pat. No. 6,506,179), the entire contents ofwhich are incorporated herein by reference. An alternative deformableretention member is taught in Snow et al. (U.S. Pat. No. 6,077,250), theentire contents of which are incorporated herein by reference.

Retention members that may be deformed in situ allow the tube 1 to beremoved without additional endoscopy. The retention member is deflatedor deformed and the tube 1 is pulled out using traction. In cases wherethe retention member is rigid, the tube 1 may be cut close to the skinand removed endoscopically.

It is preferable for the stomach to be positioned up against the innerabdominal wall. This may be accomplished by insufflation during the tubeplacement procedure and after the tube 1 has been placed due to theretention member. For example, as shown in FIG. 1, retention members atthe proximal end portion 16 and distal end portion 17 of the tube 1anchor the stomach up against the abdominal wall. The stomach may alsobe anchored to the abdominal wall by gastropexy, which may preventcomplications arising from tube placement and may facilitate theplacement procedure. In addition, jejunopexy is important in jejunostomyprocedures in order to secure the jejunum during the tube placementprocedure (see Zmen et al., supra). For example, to secure the stomachor jejunum to the abdominal wall, T-shaped metal or nylon fixing membersmay be inserted trans-gastrically or trans-jejunally close to the tubeinsertion site. The fixing members assume a T shape after insertion andare tied near to the skin. Four fixing members are typically disposed ina square pattern around the tube insertion site to secure the stomach orjejunum. (see, e.g., F. J. Thornton et al. “Percutaneous RadiologicGastrostomy with and without T-Fastener Gastropexy: a RandomizedComparison Study” Cardiovasc Intervent Radiol. 2002 November-December;25(6):467-71).

Reference is now made to various forms of pumps which are attachable tothe proximal end portion 16 of the tube 1. Any conventional pump, theconstruction of which will be readily understood to one skilled in theart, may be used. FIGS. 2 and 3, for example, display pumps 8 and 9which are attachable to the proximal end portion 16 of the tube 1 forremoval of food from the stomach 3 or upper digestive system of thepatient. It would be suitable to use a pump that extracts more than 750ml of food from the upper digestive system of a patient within 30minutes or less. The pump may be operated intermittently to prevent tubecollapse, tube clogging or mucosal irritation. The pump may be manual orbattery operated. Optionally, a rechargeable power supply may beincorporated into the pump, and the pump may be configured to be carriedon a patient's belt.

FIG. 2 depicts a manual bulb pump 8 that is attached to the proximal endportion 16 of the tube 1 and is operated to remove food from thepatient's upper digestive system through the tube 1. The manual bulbpump 8 preferably comprises silicone rubber or a similar flexiblematerial so as to permit the contents of the bulb pump 8 to be evacuatedby squeezing the bulbous end of the bulb pump 8. The circumference of atapered end essentially corresponds to an interior circumference of thelumen 25 of the tube 1. To operate the manual bulb pump 8, air is firstevacuated from the bulb pump 8 by squeezing the bulb, and then thetapered end of the bulb pump 8 is inserted into the lumen 25 of theproximal end portion 16 of the tube 1 so as to create a seal between thetapered end and the tube 1. The bulb is then released to allow it tore-inflate. The negative pressure in the bulb pump 8 (when it isreleased) causes food to flow out from the upper digestive system towardthe proximal end portion 16 of the tube 1 and into the bulb of themanual bulb pump 8. The bulb pump 8 is then disengaged from the tube 1and the removed food is evacuated from the bulb. The cycle may berepeated until a desired amount of food is removed from the upperdigestive system of the patient.

FIG. 3 depicts another pumping arrangement in which a pump in the formof a syringe 9 is attached to the proximal end portion 16 of the tube 1and is operated to remove food from the patient's upper digestive systemthrough the tube 1. The syringe 9 preferably comprises a tapered endportion with an aperture at the distal end thereof. The circumference ofthe tapered end portion 9 a corresponds to the interior circumference ofthe lumen 25 of the tube 1. To operate the syringe 9 to remove food fromthe upper digestive system of the patient, the contents (air or food) ofthe syringe 9 are evacuated by depressing the plunger. The tapered endportion 9 a of the syringe 9 is inserted into the proximal end portion16 of the tube 1 so as to create a seal between the tapered end portion9 a and the tube 1. The plunger of the syringe 9 is then withdrawn so asto create negative pressure to draw food out from the upper digestivesystem through the tube 1 and into the syringe 9. The syringe 9 is thendisengaged from the tube 1 and evacuated by, for example, depressing theplunger thereof. 60 cc is an example of a suitable size for the syringe9. The cycle may be repeated until a desired amount of food is removedfrom the upper digestive system of the patient.

The manual bulb pump 8 and syringe 9 may be activated by the patient orby a health care provider at a predetermined time after eating. Thepredetermined time is preferably set by a physician and, for example,may be 20-30 minutes. A physician may also determine a maximum volume offood to be removed from the upper digestive system of the patient aftereach meal. The maximum volume may be set in terms of a maximum number ofpumping cycles which is told to the patient or health care provider ifthe pump 8, 9 is manually operated.

In a preferred embodiment, the pump that is used to extract food fromthe patient's upper digestive system periodically reverses direction andpumps air and/or water into the upper digestive system of the patientduring the periods of reverse operation. The air and/or water helps tosolubilize or breakdown the food in the upper digestive system so thatit can be pumped out easily. In addition, the air and/or water helpsprevent the tube 1 from being suctioned up against the stomach wallwhile food is extracted from the upper digestive out through the tube 1.For example, every seven seconds of pumping may be followed by twoseconds of reverse operation.

FIG. 4 illustrates a variation of an embodiment of the present inventionin which the extracted food is evacuated from a pump 6 into a bag 12that is attached to the pump 6. As shown in FIG. 4, after the food ispumped out of the upper digestive system of the patient by the pump 6,the food may be stored in a bag 12 that is attachable to the proximalend portion of the pump 6. The bag 12 may be opaque, scented,biodegradeable and worn by the patient on a belt or other strap.Alternatively, as shown in FIGS. 11 and 16, the food may be pumped fromthe patient's upper digestive system into the pump 6 and then into atube 28 attached to the pump 6. The contents of the tube 28 attached tothe pump 6 may be emptied into a toilet. The tube 28 may be opaque,scented, biodegradeable and flushable down the toilet.

FIG. 5 illustrates a cleaning device being used to clean the tube 1after food has been extracted from the patient's upper digestive systemthrough the tube 1. As shown in FIG. 5, the tube 1 may be cleaned usinga brush 14 that is adapted to clean the inside of the tube 1. The pump6, manual bulb pump 8 and syringe 9 may be cleaned by flushing them withsaline and/or a disinfectant solution after use.

FIG. 6 illustrates a second embodiment of the present invention in whicha feeling of satiety is created in the patient by inflating the balloonanchor. Creating a feeling of satiety curbs the patient's hunger anddesire to eat food thereby allowing the patient to eat less and loseweight. As shown in FIG. 6, the inflation portion 2, which is theretention member that holds the tube 1 in the patient's stomach, alsoserves the function of decreasing stomach capacity to create a feelingof satiety when it is inflated. The inflation portion 2 may be variablyinflated by adding or removing fluid through the inflation lumen 26 ofthe tube 1 (shown in FIG. 1C).

FIG. 7 shows an axial cross sectional view of the tube 1 extending outfrom the skin 5 of the patient in which the removal lumen 25 and theinflation lumen 26 are visible. In a feature which may be incorporatedinto any of the various embodiments of the present invention, a valve 15is provided at the proximal end portion 16 of the tube 1 in the removallumen 25. The valve 15 ordinarily prevents food from leaving the tube 1.The valve 15 is opened when a pump is attached to the proximal endportion 16 of the tube 1. For example, the tapered end portion of themanual bulb pump 8 (shown in FIG. 2) and the tapered end portion of thesyringe 9 (shown in FIG. 3) each push open the valve 15 when they areinserted into the proximal end portion 16 of the tube 1. When the valve15 is opened by the ends of the pumps, food can be removed as describedhereinabove. A cap 13 (shown in FIG. 1) is preferably placed on theproximal end portion 16 of the tube 1 when a pump is not attached. Thecap 13 may be pressed onto the end of the tube 1, threaded on the end ofthe tube 1, or may have projections which are frictionally inserted intothe ends of lumens 25, 26 to seal them in a closed condition.

FIG. 7 also shows a valve 27 provided at the proximal end portion 16 ofthe tube 1 in the inflation lumen 26. The valve 27 prevents the fluidused to inflate the inflation portion 2 from escaping the inflationportion 2 through the inflation lumen 26. That is, the valve 27 preventsthe inflation portion 2 from deflating. If it becomes necessary todeflate the inflation portion 2 to remove the tube 1 from the upperdigestive system of the patient, or to further inflate the portion 2, aneedle on a syringe may be inserted into the inflation portion 26 so asto open the valve 27 by pushing the needle through the valve members.The fluid used to inflate the inflation portion 2 may then be removed oradded with the syringe.

FIG. 8 illustrates a third embodiment of the present invention showing atube having two balloons attached to that portion of the tube that isdisposed within the patient's upper digestive system. The balloon anchor2 is expandable to about 10 ml and is positioned up against the stomachwall to prevent the tube 1 from falling out. The inflatable balloon 29is expandable from about 100 ml to about 850 ml and may be expandedintermittently to limit the capacity of the stomach. For example, theballoon 29 may be inflated via an inflation lumen prior to a meal tocreate the sensation of being full. After the meal, the balloon 29 maybe deflated to prevent chronic accommodation. An electrically or amanually operated pump may be used to cause the inflation.

The tube 1 in this embodiment has a long inner tube length of about 10cm or longer and a diameter of 28 French (9.3 mm) in size or greater.The tube 1 may have multiple holes 32 in the sidewall of its distal endportion 17 as shown in FIG. 8 and also in FIGS. 10 and 13-15B. The holes32 may be 5×7 mm in size. The holes 32 provide non-vascular drainagefrom the patient. Preferably, the holes 32 are arranged in a spiralpattern 1 cm to 1.5 cm apart without losing structural integrity. Morepreferably, cushions or bumpers (not shown) are located on the tube 1and in between the holes 32 to prevent the tube from being sucked upagainst the stomach wall while food is extracted from the upperdigestive system out through the tube 1. For example, cushions orbumpers that are raised 3-4 mm above the surface of the tube 1 may beused for this purpose.

As shown in FIG. 8, a second retention member 33 may be attached at theproximal end portion 16 of the tube 1 to keep the tube 1 fixed to theabdominal surface. This second retention member may be similar to theretention members described hereinabove and shown in FIGS. 1, 1A, 1B and6. The distance between the second retention member 33 at the proximalend portion 16 of the tube 1 and the balloon anchor 2 at the distal endportion 17 of the tube 1 can be adjusted to account for the varyingamount of intervening tissue 40, 40′ as shown in FIGS. 15A and 15B. Forexample, the second retention member 33 may be attached to the tube 1via an interference or friction fit. Specifically, the second retentionmember 33 may be placed around the outer surface of the proximal endportion 16 of the tube 1 and held in place on the tube 1 if it has aninner diameter that is slightly smaller than the outer diameter of thetube 1. As the patient loses weight, the proximal end portion 16 of thetube 1 extends farther and farther away from the patient's abdominalsurface. A physician or the patient can slide the second retentionmember 33 down towards the abdominal surface and the excess amount ofthe tube 1 can be cut off.

FIG. 9 illustrates a fourth embodiment of the present invention with atube 1 having a curved configuration at its distal end portion 17 and aplurality of holes 32 in a sidewall. As shown in FIG. 9, the distal endportion 17 of the tube 1 is adapted to assume a curved configurationwhen disposed in the upper digestive system of a patient. Specifically,the distal end portion 17 of the tube 1 is flexible to facilitateinsertion and removal from the patient. When the distal end portion 17of the tube 1 is disposed in the upper digestive system of the patient,it returns to its natural curved configuration. The tube's tendency toreturn to its natural curved configuration may be achieved, for example,by bending the tube into a desired curved shape during the manufacturingprocess before the tube has fully cured or cooled, or by incorporatingshape memory materials into the tube. As used herein, the term “curved”includes flexed, bent, rounded, arched, curled, coiled, spiral, andpigtail. This curved configuration is preferable because it increasesthe intake area within the upper digestive system. In addition, thecoiled distal end portion 17 of the tube 1 as shown in FIG. 10 helps tomaintain the position of the tube 1 within the patient's upper digestivesystem. The distal end portion 17 of the tube 1 may, for example, beabout 10 cm long or longer to improve the intake of the food from theupper digestive system. Retention members (not shown) similar to theones described in the above embodiments may also be used in thisembodiment.

In an alternative embodiment (not shown), an actuating mechanism isconfigured to bend the distal end portion 17 of the tube 1 into a curvedconfiguration. The actuating mechanism may, for example, be a stringattached to the distal end portion 17 of the tube 1 that, when retractedcauses the tube to assume a curved configuration (e.g. a loop with anarc that measures between about 270°-360°). A Cope Loop is a well knownexample of this arrangement.

FIG. 10 illustrates a fifth embodiment of the present invention showinga tube 1 having a curved configuration, multiple holes 32 in a sidewall,and a morcellation device 36 housed within a housing 37 at its distalend portion 17. Examples of morcellation devices are disclosed in U.S.Pat. Nos. 5,618,296, 5,741,287 and 5,520,634, herein incorporated byreference in their entirety. As shown in FIG. 10, a morcellation device36 is provided at the distal end portion 17 of the tube 1 to divide andgrind food into smaller pieces as it enters the tube 1. The morcellationdevice 36 thus allows large food to be removed from the patient withoutclogging the tube 1. The morcellation device 36 can be, for example, amechanical propeller provided within a housing 37 at the distal endportion 17 of the tube 1. The housing 37 is constructed to protect bodytissue from the morcellation device 36. In the illustrated embodiment,the housing 37 has an opening to permit the entry of food from thepatient into the tube 1 and may, for example, be a cage that surroundsthe morcellation device 36 at the distal end portion 17 of the tube 1.It is preferable that the housing 37 is collapsible in both directionsso that it can be easily inserted into and taken out of the patient. Thehousing 37 is necessary to prevent damage to the stomach.

FIG. 11 illustrates a feature that may be used with any embodiment ofthe present invention in which the proximal end portion 16 of the tube 1lies substantially flush with the outer surface of the patient'sabdomen. This may be achieved by using ribbons attached to the tube 1,for example at the internal retention member. The ribbons are used topull the tube 1 taut when the distal end portion 17 of the tube 1 isdisposed in the upper digestive system of a patient. While the ribbonsare pulled, the proximal end portion 16 of the tube 1 is cut so that theproximal end portion 16 lies flush with the abdominal surface and athin, hollow cylinder with flanges is wedged onto the outside or insidesurface of the tube 1 via friction or by screwing it onto the tube 1 toretain the tube 1 in its position and to keep it flush with theabdominal surface. In alternative embodiments, the proximal end portion16 of the tube 1 may extend out past the abdominal surface by anydesired length (e.g., 1-10 inches).

FIG. 12 illustrates another feature that may be used with any embodimentof the present invention in which a luer lock 34 is utilized at theproximal end portion 16 of the tube 1. In this embodiment, the pump 6 isattached to the tube 1 by screwing the pump 6 onto the tube 1 around theexternal portion of the proximal end portion 16 of the tube 1 ratherthan being inserted into the tube 1. More specifically, the proximal endportion 16 of the tube 1 comprises concentric grooves or threads on theoutside to accommodate the pump 6, which prevents the pump 6 fromreducing the size of the removal lumen 25. Likewise, the pump 6 may havecorresponding concentric grooves or threads that allow it to interactand connect with the luer lock 34. In this way, large pieces of food canstill be extracted out of the tube 1 because the inner diameter of thetube 1 is not compromised or decreased due to the pump 6 being insertedinto the tube 1. Instead, the pump 6 is coupled to or threaded onto theoutside of the proximal end portion 16 of the tube 1.

FIG. 13 illustrates yet another feature that may be used with anyembodiment of the present invention in which the tube 1 has a funnelshaped tip 35. The funnel tip is advantageous because it facilitates theextraction of larger pieces of food into the tube 1 from the patient'sdigestive system.

FIG. 14 illustrates a sixth embodiment of the present invention that hastwo intake tubes. In this embodiment, both of the intake tubes 38 have acurved configuration and a sidewall with a plurality of holes 32 locatedtherein. Each intake tube 38 comprises a proximal end portion 39 anddistal end portion 40. The apparatus also comprises an output tube 41having a proximal end portion and a distal end portion 42. One or moreretention members (not shown) are preferably attached to the output tube41 to prevent the apparatus from coming out of the upper digestivesystem. The plurality of intake tubes 38 are configured to be disposedin the upper digestive system of the patient and the output tube 41 isconfigured to pass through the patient's abdominal wall when theplurality of intake tubes 38 are so disposed. The distal end portion 42of the output tube 41 is operatively connected to the proximal endportion 39 of each of the plurality of intake tubes 38 so that food canbe extracted from the upper digestive system of the patient through thedistal end portion 40 of each of the plurality of intake tubes 38 andout through the proximal end portion of the output tube 41.

Optionally, pressure and/or flow sensors (not shown) may be placed onand/or in the tube 1. Pressure sensors placed on the tube 1 inside andoutside the stomach 3 may be used to estimate the satiety of thepatient. Alternatively or in addition to, flow sensors that are placedinside the tube 1 may be used to calculate the volume of food extractedthrough the tube 1.

Reference is now made to various methods for extracting food, forlimiting absorption of food, and for treating obese patients.

Installation of any of the above-described embodiments forms apassageway into a patient's upper digestive system through the patient'sabdominal wall. The patient is allowed to carry out his/her everydayaffairs including ingesting food. After the patient has ingested food,the food is extracted by pumping it out of the upper digestive systemthrough the passageway before it is completely digested. This method andthe others described below are less invasive than the alternativesurgical procedures for reducing weight, are easy to perform, easy toreverse and have successfully resulted in significant weight loss inobese patients.

In one method, a tube is positioned so that it passes through apatient's abdominal wall into his/her upper digestive system. Thepatient is allowed to go about his/her daily activities includingingesting food. After the patient has ingested the food, the food isextracted from the upper digestive system of the patient through thetube. The patient may eat and extract the eaten food from his/her upperdigestive system through the tube repeatedly until a desired weight lossis attained. The food that has been extracted is not reintroduced intothe patient. The tube may be kept in the patient's upper digestivesystem for extended periods of time (e.g., one month or more) while theeating/extracting is repeated numerous times (e.g., 20 times or more)while the tube is in place.

In a second method, a tube is positioned so that it passes through theobese patient's abdominal wall into his/her upper digestive system. Theobese patient is allowed to go about his/her daily activities includingingesting food. After the obese patient has ingested the food, the foodis extracted from the upper digestive system of the obese patientthrough the tube. The obese patient may eat and extract the eaten foodfrom his/her upper digestive system through the tube repeatedly untilthe obese patient has lost at least 40 pounds. The food that has beenextracted is not reintroduced back into the obese patient.

In a third method, a tube is positioned so that it passes through apatient's abdominal wall into the upper digestive system of the patientwhose gastrointestinal tract is unobstructed. The term “unobstructed,”as used herein, refers to a gastrointestinal tract that is notmechanically obstructed and is also not functionally obstructed. Thepatient is allowed to go about his/her daily activities includingingesting food. After the patient has ingested the food, the food isextracted from the upper digestive system of the patient through thetube. The patient may eat and extract the eaten food from his/her upperdigestive system through the tube repeatedly until a desired weight lossis attained. The tube may be kept in the patient's upper digestivesystem for extended periods of time (e.g., one month or more) while theeating/extracting is repeated numerous times (e.g., 20 times or more)while the tube is in place.

Preliminary trials in human patients have been successful. For example,one female patient, middle aged and weighing 100 kilograms(approximately 220 pounds), had a tube installed in her stomach for 59weeks and successfully lost 38.45 kilograms (approximately 85 pounds)without experiencing any serious adverse side effects. During the 59weeks, the female patient aspirated after breakfast and lunch mealsdaily. She consumed meals without any fluids over approximately 30minutes. At the end of the meal, she consumed 52 ounces of water inapproximately 3-4 minutes. She waited approximately 20 minutes afterconsuming the water before beginning the extraction procedure.Accordingly, the patient uncapped the tube, connected a 60 cc syringe tothe tube and extracted food from her stomach twice. This resulted in asiphon effect, which permitted the subject to freely drain the stomachby allowing the open tube to empty into a bucket. The patient squeezedthe tube to enhance propulsion and to break up large food. Afterdraining stopped, the patient usually drank another 52 ounces of waterand repeated the extraction procedure. She usually repeated thisprocedure (drinking and extracting) about 2 more times, until she felther stomach was empty. The total amount of food extracted wasapproximately 2-3 liters and the entire procedure took about 20 minutes.If resistance to extraction occurred during the procedure, the patientflushed the tube with 30 cc of water. The water helped to extract thefood by dissolving it and by cleaning the passageway. The patientchanged her dietary intake to avoid tube clogging. She avoided eatingcauliflower, broccoli, Chinese food, stir fry, snow peas, pretzels,chips, and steak. In addition, her diet was supplemented with potassium.The chart below illustrates her weight loss.

weight Week (kg) 0 100.9 2 96.8 3 96.8 4 94.7 4 94.7 5 94.0 7 93.6 890.9 9 92.9 10 92.7 11 90.4 12 89 13 89.3 14 88.6 15 87.7 16 86.5 1786.5 18 86.3 19 85.9 20 83.9 21 82.9 22 81.6 23 80.45 24 79.7 25 78.6 2678.6 27 77.2 28 78 29 76.2 30 76 31 75.2 31 77.1 32 76.4 33 76.4 34 76.435 74 36 74 37 74 38 73.6 39 73.5 40 73.2 41 72.6 42 71.22 43 69.5 4469.8 45 69.45 46 68.45 47 66.6 48 65.5 49 65.5 50 65.5 51 65.2 52 65 5365 54 64.5 55 64.8 56 64.8 57 63.8 58 63 59 62.45

It is noted that the food extraction apparatuses and methods describedabove are preferably combined with a behavior modification program thatideally educates patients in modifying caloric intake, lifestyle andattitudes toward food. Learned activities and support for weight lossmay include activities such as self-monitoring by recording food intakeand physical activity, avoiding triggers that prompt eating, assistancefrom family and friends, problem solving skills and relapse prevention.The program may be taught by an instructor or offered over the internet.In addition, the program preferably includes a series of regularcheck-ups by a health care provider. The check-ups ideally includeregularly testing blood for electrolytes, supplementing patients' dietswith vitamins, and administering medications to prevent gallstoneformation as needed. Ideally, the behavior modification program willeducate patients to change their lifestyle so as to eliminate the needfor food extraction.

The above described embodiments allow obese patients to lose weightwithout undergoing drastic and invasive surgeries. As a result, obesepatients avoid many of the complications associated with such surgeries.In addition, the present invention is easy to perform, easy to reverseand allows obese patients to live a normal and active lifestyle withfewer adverse side effects.

Optionally, the embodiments described above may be used in conjunctionwith an artificially created partial obstruction or restriction of thegastrointestinal tract to restrict food intake and/or delay foodemptying from the stomach to the small intestines. Examples of suchrestrictions can be found in patent applications US2003/0040808 andUS2006/0264983, which are incorporated herein by reference. Note thatwhile those two applications describe restrictions introduced at thegastro-esophageal junction region or at the stomach, restrictions orobstructions could also be introduced at other portions of thegastrointestinal tract. Such examples of restriction devices includegastric balloons, tubular stomach pouches, and mechanical gastricrestrictor devices. As described in US2006/0264983, such devices includegastric restrictor assemblies such as those comprising a housing; avalve assembly supported within the housing, the valve assembly defininga throughbore through the housing and being actuable to selectivelyadjust an area of the throughbore; and an attachment mechanism supportedby the housing, the attachment mechanism having at least one fasteningelement and being actuable to move the fastening element to a positionsecuring the gastric restrictor assembly to an inner wall of a lumen.

Combining the aspiration of food from the upper digestive tract of thepatient with an obstruction or restriction of the gastrointestinal tractcan provide synergistic benefits that promote weight loss. Thiscombination can enhance the efficiency of food removal from the stomachand potentially provide increased satiety between meals. When anartificial restriction is used, the time between eating a meal and theevacuation may be maintained at the same level described above for theembodiment that do not include a restriction (i.e., 20-30 minutes). Butwhen an artificially introduced restriction slows down the absorption offood, the patient could wait a longer period of time before aspiratingthe food from the stomach via the tube (e.g., between 30 and 60 minutesafter eating), and still achieve equivalent food removal withpotentially greater mechanical breakdown of the larger particles in thechyme.

Additional advantages and modifications will readily occur to thoseskilled in the art. For example, the features of any of the embodimentsmay be used singularly or in combination with any other of theembodiments of the present invention. In addition, the insertiontechnique for placing the tube is not limited to known gastrostomytechniques. Accordingly, various modifications may be made withoutdeparting from the spirit or scope of the general inventive concept asdefined by the appended claims and their equivalents.

We claim:
 1. A method of achieving weight loss in a patient, wherein thepatient's gastrointestinal tract is unobstructed, comprising the stepsof: (a) positioning a tube that passes through the patient's abdominalwall into the patient's stomach; (b) introducing an artificialrestriction in the patient's digestive system; (c) allowing the patientto ingest food and allowing the ingested food to accumulate in thepatient's stomach; and (d) waiting until after the patient has finishedingesting the food and subsequently extracting the food from thepatient's stomach through the tube.
 2. The method of claim 1, furthercomprising the step of repeating steps (c) and (d) until the patient haslost at least 40 pounds.
 3. The method of claim 1, further comprisingthe step of keeping the tube in the patient for at least one month andrepeating steps (c) and (d) at least 20 times to achieve weight loss inthe patient.
 4. The method of claim 1, wherein step (d) compriseswaiting about 20 minutes and subsequently extracting the food from thepatient's stomach through the tube.
 5. The method of claim 1, wherein instep (d), the food is extracted by pumping the food out of the patient'sstomach through the tube.
 6. The method of claim 1, further comprisingthe step of monitoring how much food is extracted in step (d).
 7. Amethod of achieving weight loss in a patient, wherein the patient'sgastrointestinal tract is unobstructed, comprising the steps of: (a)introducing a passageway into a stomach of the patient such that thepassageway passes through the patient's abdominal wall; (b) introducingan artificial restriction in the patient's digestive system; (c)allowing the patient to ingest food and allowing the ingested food toaccumulate in the patient's stomach; and (d) waiting for partialdigestion of the ingested food to occur in the patient's stomach, andsubsequently extracting the food from the patient's stomach through thepassageway.
 8. The method of claim 7, further comprising the step ofrepeating steps (c) and (d) until the patient has lost at least 40pounds.
 9. The method of claim 7, further comprising the step of keepingthe passageway in the patient for at least one month and repeating steps(c) and (d) at least 20 times to achieve weight loss in the patient. 10.The method of claim 7, wherein step (d) comprises waiting about 20minutes and subsequently extracting the food from the patient's stomachthrough the passageway.
 11. The method of claim 7, wherein theintroducing step comprises positioning a tube that passes through thepatient's abdominal wall into the patient's stomach.
 12. The method ofclaim 11, wherein in step (d), the food is extracted by pumping the foodout of the patient's stomach through the tube.
 13. The method of claim7, further comprising the step of monitoring how much food is extractedin step (d).
 14. A method of achieving weight loss in a patient, whereinthe patient's gastrointestinal tract is unobstructed, comprising thesteps of: (a) positioning a tube that passes through the patient'sabdominal wall into the patient's stomach, wherein the patient'sgastrointestinal tract is unobstructed; (b) introducing an artificialbody in the patient's digestive system configured to give rise to afeeling of satiety; (c) allowing the patient to ingest food and allowingthe ingested food to accumulate in the patient's stomach; and (d)waiting until after the patient has finished ingesting the food andsubsequently extracting the food from the patient's stomach through thetube.
 15. The method of claim 14, further comprising the step ofrepeating steps (c) and (d) until the patient has lost at least 40pounds.
 16. The method of claim 14, further comprising the step ofkeeping the tube in the patient for at least one month and repeatingsteps (c) and (d) at least 20 times to achieve weight loss in thepatient.
 17. The method of claim 14, wherein step (d) comprises waitingabout 20 minutes and subsequently extracting the food from the patient'sstomach through the tube.
 18. The method of claim 14, wherein in step(d), the food is extracted by pumping the food out of the patient'sstomach through the tube.
 19. The method of claim 14, further comprisingthe step of monitoring how much food is extracted in step (d).
 20. Themethod of claim 14, the artificial body capable of effectivelydecreasing the patient's stomach capacity.
 21. The method of claim 14,the artificial body comprising a retention member.
 22. The method ofclaim 14, the artificial body being capable of effectively decreasingthe patient's stomach capacity.
 23. The method of claim 1, wherein theartificial restriction is a gastric balloon, a tubular stomach pouch, ora mechanical gastric restrictor device.
 24. The method of claim 1,wherein the tube that passes through the patient's abdominal wall intothe patient's stomach comprises an inflatable balloon or balloon anchoror both, positioned within the patient's stomach, and introducing theartificial restriction in the patient's digestive system comprisesinflating said inflatable balloon or balloon anchor or both.